Cleared Traditional

TheraBase, TheraBase Ca

K192007 · Bisco, Inc. · Dental
Mar 2020
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K192007 is an FDA 510(k) clearance for the TheraBase, TheraBase Ca, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on March 17, 2020, 232 days after receiving the submission on July 29, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K192007 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2019
Decision Date March 17, 2020
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275